MAUDE report

MAUDE report 6571: LUMEX

Injury · received Sep 28, 1993 · DIVISION OF LUMEX INC.

Key facts

MDR report key 6571
Report number 6571
Event type Injury
Brand name LUMEX
Model number UNKNOWN
Catalog number 5740
Manufacturer DIVISION OF LUMEX INC.
Product code INN
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Sep 28, 1993
Report date Sep 9, 1993
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 10–99 Injury reports for this brand
  • Yes Adverse event flagged
  • No Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

Browse all MAUDE medical device reports